EPT 100: Geranium Oil for the Relief of Neuropathic Pain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Alok K. Gupta, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier:
NCT01007747
First received: November 3, 2009
Last updated: June 19, 2013
Last verified: June 2013
  Purpose

The purpose of this study is to determine if Geranium oil will relieve a variety of neuropathic pain and some pain relief will last more than 48 hours.


Condition Intervention
Neuropathic Pain
Other: Geranium oil

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: EPT 100: Geranium Oil for the Relief of Neuropathic Pain

Further study details as provided by Pennington Biomedical Research Center:

Primary Outcome Measures:
  • Pain relief [ Time Frame: 3 times in 30 to 60 minutes post-application ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Response to therapy at 30 to 60 minutes, they will be asked to apply the oil to painful area daily [ Time Frame: Daily over 1 week ] [ Designated as safety issue: No ]

Enrollment: 166
Study Start Date: November 2008
Study Completion Date: October 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Geranium oil Other: Geranium oil
Daily topical application over neuropathic pain

Detailed Description:

EPT 100 study is designed to identify the percentage of people who experience neuropathic pain relief from topical geranium oil from Reunion Island, determine which neuropathic pain conditions respond best and define the time course of the pain relief.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 years of age or oler
  • Neuralgia or neuropathy with daily pain
  • At least moderate intensity pain
  • Signed informed consent

Exclusion Criteria:

  • Pregnant or nursing
  • Known allergies to geranium oil or geranium oil fractions
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01007747

Locations
United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
  More Information

No publications provided

Responsible Party: Alok K. Gupta, Principal Investigator, Pennington Biomedical Research Center
ClinicalTrials.gov Identifier: NCT01007747     History of Changes
Other Study ID Numbers: PBRC21033
Study First Received: November 3, 2009
Last Updated: June 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Pennington Biomedical Research Center:
Geranium oil
Neuropathy

Additional relevant MeSH terms:
Neuralgia
Nervous System Diseases
Neurologic Manifestations
Neuromuscular Diseases
Pain
Peripheral Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on October 21, 2014